NIZORAL*CREAM DERM 30G 2%

NIZORAL 2% cream
Ketoconazole

What it is and what it is used for
NIZORAL contains an active ingredient called ketoconazole, belonging to a group of medicines that kill fungi, called antifungals.

NIZORAL cream is used against skin infections caused by fungi or yeasts, cutaneous candidiasis, which can cause problems such as:
• widespread inflammation, characterized by reddish lesions with fluid (candidiasis) or white to brown skin spots that sometimes appear after sun exposure (tinea versicolor);
• inflammation on limited parts of the body, such as the chest and/or back (tinea corporis), hands (tinea manus), feet (tinea pedis) or groin area (tinea cruris), characterized by patchy redness, blister formation, skin peeling;
• dry or oily skin flaking, called seborrheic dermatitis.
These conditions can cause itching.

NIZORAL cream can be used in adults over 18 years of age.

What you need to know before taking the medicine
Do not use NIZORAL
if you are allergic to the active ingredient or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using NIZORAL if:
• you are elderly;
• you have liver problems;
• you have previously used medicines containing griseofulvin, which are used to kill fungi.

Be careful with NIZORAL cream
• If you are using a lotion or cream on your skin that contains a corticosteroid (e.g. betamethasone or hydrocortisone):
   - continue to apply a small amount of the corticosteroid-containing lotion or cream in the morning; apply NIZORAL cream in the evening;
   - progressively decrease the amount of the corticosteroid-containing lotion or cream during the first 2-3 weeks of treatment with NIZORAL cream;
   - after 2-3 weeks, use only NIZORAL. This will prevent symptoms from worsening before NIZORAL starts to take effect.
• During treatment with NIZORAL, observe hygiene measures to avoid new infections or worsening of symptoms due to reinfection.
• Do not use NIZORAL cream on the eyes.

Like other medicines for local (topical) use, especially with prolonged therapy, NIZORAL cream can cause redness and itching (sensitization phenomena). If this occurs, stop treatment and consult your doctor.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Inform your doctor if, during the use of NIZORAL cream, you notice:

Common side effects (may affect up to 1 in 10 people)
• redness or itching at the application site of the cream;
• burning sensation of the skin.

Uncommon side effects (may affect up to 1 in 100 people)
• redness, itching and burning due to irritation, bleeding, discomfort, dryness, loss of sensation (paresthesia) or other lesions at the application site of the cream;
• sudden appearance of skin lesions, such as patchy or widespread color changes (rash) or blister formation, skin inflammation (dermatitis), skin exfoliation;
• sticky skin;
• allergic reactions including redness and itching, with possible swelling of the face, eyes, throat and difficulty breathing.

Other side effects (frequency not established)
• hives.

Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.